Xeleris Processing and Review Workstation

GUDID 00195278245021

Xeleris V Clinical Application SW

G E MEDICAL SYSTEMS ISRAEL LTD.

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• Primary Device ID: 00195278245021
• NIH Device Record Key: 245b99d3-9026-4fd7-831f-a10230c139af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xeleris Processing and Review Workstation
• Version Model Number: V
• Company DUNS: 532102365
• Company Name: G E MEDICAL SYSTEMS ISRAEL LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278245021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201103

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-20
• Device Publish Date: 2021-05-12

On-Brand Devices [Xeleris Processing and Review Workstation]

• 00840682147545: 4.1450
• 00840682134897: 4.1
• 00840682109819: 4.0
• 00195278245021: Xeleris V Clinical Application SW